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Efficacy of a Herbal Formula for Bone Metastases

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06023420
Collaborator
(none)
36
Enrollment
2
Arms
11
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Nearly 50% of patients with bone metastases develop one or more complications collectively termed skeletal-related events (SREs). The study herbal medicine might reduce the morbidities due to "Skeletal-related events" (SRES), and extend survival time.

PURPOSE: the study is to explore the effects of the 4 Herbs Formula on the reduction of "Skeletal-related events" (SRES), and survival time.

Condition or Disease Intervention/Treatment Phase
  • Drug: 4 Herbs Formula
 Phase 1/Phase 2

Detailed Description

OBJECTIVES:

Primary Primary efficacy end points are SRE, general state and biomarkers. Secondary Survival rate and survival time Time to first SRE (since randomization) Biochemical markers Quality of Life: EQ5-D Pain control (Brief Pain Inventory)

OUTLINE:

Patients will be randomized to receive either 4 herbs formula plus Zometa or Zometa alone after all the eligibility criteria have been fulfilled and informed consent has been signed.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Using A Special 4 Herbs Formula For The Palliative Care Of Patients Suffering From Bone Secondaries
Anticipated Study Start Date :
Feb 1, 2024
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

Herbal formula 5g daily, and Zometa

Drug: 4 Herbs Formula
4 herbs formula dose: 5g/day
Other Names:
  • Zometa

    		•
    Active Comparator: Control group

    Zometa alone

    Drug: 4 Herbs Formula
    4 herbs formula dose: 5g/day
    Other Names:
  • Zometa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. reducing the morbidities of "Skeletal-related events" (SRES) extending survival time [3 months]

      SREs are defined as pathologic fractures, spinal cord compression, surgery to bone, radiation therapy to bone, and hypercalcemia of malignancy (HCM).

    Secondary Outcome Measures

    1. Survival rate and survival time [Proportion of participants in all groups with overall survival at 1 year]

      Proportion of participants in each group with overall survival at 6 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Aged 18 years or older

    • Breast cancer bone metastasis-no supplementary treatment or hormonal treatment alone

    • Confirmed diagnosis of metastatic breast cancer

    • Radiographic proof of metastatic bone disease

    • Informed consent obtained

    Exclusion Criteria:

    • Known history of primary bone tumors (benign and/or malignant)

    • Prior use of bone modifying agents, including but not limited to zoledronic acid or denosumab within 12 months of study entry

    • Active anti-cancer therapies in the form of cytotoxics or targeted therapies. [Patients who are currently on hormonal therapies, including but not limited to tamoxifen, aromatase inhibitors and LHRH agonists/antagonists are allowed for study entry. Clarifications shall be sought from investigators if in doubt].

    • Significant drug hypersensitivity

    • No informed consent signed

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Chinese University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cheng King Fai, Principal Investigator, Chinese University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT06023420
    Other Study ID Numbers:
    • 2021.746-T
    First Posted:
    Sep 5, 2023
    Last Update Posted:
    Sep 7, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasm Metastasis

    Study Results

    No Results Posted as of Sep 7, 2023